(153 days)
There are no Predicate Device(s) identified in the provided text. The text explicitly states "Predicate Device(s) Not Found".
Not Found
No
The summary describes a standard blood glucose monitoring system and contains no mention of AI, ML, or related technologies.
No.
The device measures blood glucose levels which is a diagnostic function, not a therapeutic one. While it assists in diabetes management, it does not directly treat or cure the condition.
Yes
The device is described as assisting in the "management of diabetes" and provides "quantitative determination of glucose," which are diagnostic actions for monitoring a medical condition.
No
The intended use describes a "Blood Glucose System" which typically involves a physical meter and test strips to measure glucose in blood. The summary does not mention any software-only components or functionalities.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states "quantitative determination of glucose in human whole blood taken from the finger or forearm." This involves testing a biological sample (whole blood) outside of the body to obtain diagnostic information (glucose levels).
- Purpose: The system is intended "to assist the patient and Healthcare Professional in the management of diabetes." This indicates a diagnostic purpose related to a medical condition.
These characteristics align with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The TRUE2go Blood Glucose System is intended for the quantitative determination of glucose in human whole blood taken from the finger or forearm. The System is intended to be used to assist the patient and Healthcare Professional in the management of diabetes.
Healthcare Professionals may use the device to test venous whole blood; home-use is limited to capillary whole blood testing.
Not for neonatal use.
Product codes
NBW, LFR
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
finger or forearm
Indicated Patient Age Range
Not for neonatal use.
Intended User / Care Setting
patient and Healthcare Professional
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Not Found
Key Metrics
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 862.1345 Glucose test system.
(a)
Identification. A glucose test system is a device intended to measure glucose quantitatively in blood and other body fluids. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.(b)
Classification. Class II (special controls). The device, when it is solely intended for use as a drink to test glucose tolerance, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.
0
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized depiction of an eagle with its wings spread, positioned above a circular seal. The seal contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" arranged around the perimeter.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
AUG 1 3 2008
Home Diagnostics, Inc. c/o Karen De Vincent Director of Regulatory Affairs/Quality Assurance 2400 N.W. 55th Court Fort Lauderdale, FL 33309
Re: K080710 Trade Name: TRUE2go Blood Glucose Monitoring System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Codes: NBW, LFR Dated: August 4, 2008 Received: August 5, 2008
Dear Ms. DeVincent:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
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This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to 1egally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240) 276-0490. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its tolloffram mber (800) 638-2041 or (240) 276-3150 or at its Internet address at http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Jean M. Cooper, M.S., D.V.M.
Jean M. Cooper, M.S., D.V.M. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known): K080710
Device Name: TRUE2go Blood Glucose Monitoring System
Indications for Use:
The TRUE2go Blood Glucose System is intended for the quantitative determination of glucose in human whole blood taken from the finger or forearm. The System is intended to be used to assist the patient and Healthcare Professional in the management of diabetes.
Healthcare Professionals may use the device to test venous whole blood; home-use is limited to capillary whole blood testing.
Not for neonatal use.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
の 2006年のモノベーション 2007年08月10日 10:00 【 1000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000
Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OVID)
Carol C. Benson
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K080710